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Mifepristone and Misoprostol for Fetal Demise (MIMID)

This study has been completed.
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: September 12, 2005
Last updated: January 28, 2016
Last verified: January 2016
This is a pilot clinical trial to evaluate whether the medical management of early pregnancy failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects with early pregnancy failure receive mifepristone followed 24 hours later by vaginal misoprostol for medical management. Subjects then return on study day 3 for a repeat ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol, and in person for those who received a second dose. Questionnaires are administered at the beginning and end of the study to determine acceptability.

Condition Intervention Phase
Anembryonic Pregnancy Gestation Abnormality Intrauterine Fetal Demise Term Drug: mifepristone/misoprostol Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment [ Time Frame: 1-2 weeks ]

Secondary Outcome Measures:
  • to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications [ Time Frame: 1-2 weeks ]
  • to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure [ Time Frame: 1-2 weeks ]
  • to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure [ Time Frame: 1-2 weeks ]

Enrollment: 30
Study Start Date: January 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
Drug: mifepristone/misoprostol
mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
Other Name: Mifeprix/Cytotec


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria: healthy hemodynamically stable females with a non-viable pregnancy

Exclusion Criteria:

  • orthostatic hypotension, contraindication to either mifepristone or misoprostol, treatment during current pregnancy to provide surgical or medical evacuation of the uterus, evidence of ovarian hyperstimulation syndrome, known or suspected pelvic infection,known or suspected clotting defect or receiving anticoagulants, cardiovascular disease, current breastfeeding, pregnancy with and IUD in situ, current participation in another clinical trial, prior participation in this trial, suspected or confirmed endometrial AV malformation, clinical indication requiring the karyotyping of products of conception
  Contacts and Locations
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Please refer to this study by its identifier: NCT00177372

United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Mitchell D Creinin, MD Magee-Womens Hospital
  More Information

Responsible Party: University of Pittsburgh Identifier: NCT00177372     History of Changes
Other Study ID Numbers: Pittirb0409119
Study First Received: September 12, 2005
Last Updated: January 28, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fetal Death
Pregnancy Complications
Pathologic Processes
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents processed this record on September 20, 2017